82 ADRAGOS PHARMA Generic drugs play a vital role in healthcare, offering patients affordable alternatives to brand-name medications. However, like any drug, their development and approval require a rigorous process to ensure safety and, most importantly, an efficacy that is comparable to the original drugs. Generic drugs are a mainstay of patient treatment, and represent more than 90% of the drugs taken by patients in the United States, and about two-thirds of those in Europe.1 Unlike innovator drugs that must undertake extensive clinical trials to prove their efficacy and safety in patients for the first time, generics must only prove to regulators that they are safe and efficacious as the original product. As part of this process, comparative bioavailability studies, also known as bioequivalence studies, are commonly carried out. These are designed to prove that the outcomes of treatment would be the same, regardless of whether it was the innovator or the generic version that a patient is given. The trials compare the rate and extent of absorption of the two products, and if the results are comparable, then the therapeutic outcome should also be equivalent, avoiding the need for a more extensive - and costly - efficacy study. The assumption is that if its absorption is similar, its efficacy will be, too. Designing effective bioequivalence studies Not all products require bioequivalence studies; in some cases, scientific data from laboratory experiments will suffice. However, in most cases, they are required, and it is essential that the design of the study is undertaken carefully to ensure meaningful and validated results are achieved. It may be that where the drug has a complex dosage forms, or involves a molecule with inherent variability, it is prescient to run an initial pilot study, which can give an indication that a larger study would be likely to succeed to reduce the developmental risk. This is not always necessary, and in some situations proceeding directly to the pivotal study does not carry significant risk. The design process of bioequivalence studies should always focus on a close understanding of precisely what the regulators will be looking for, and offer a pathway that should lead to approval, and identify any potential complications or obstacles along the way. There are a number of choices and decisions TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025
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